MiBiotix SHAPE SP PILL

MIBIOTIX SP SHAPE CAPSULES 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix SP SHAPE CAPSULES.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix SP SHAPE CAPSULES (capsules).

Read all of this leaflet carefully because it contains important information for you.

MiBiotix SP SHAPE CAPSULES are available without a doctor’s prescription. Nevertheless, you still need to use MiBiotix SP SHAPE CAPSULES carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix SP SHAPE CAPSULES with any other person.
  • Ask your pharmacist if you need more information or advice.
  • You must see a doctor if your symptoms worsen or do not improve.


1. WHAT MIBIOTIX SP SHAPE CAPSULES CONTAINS: 

10 Billion CFU’s of Bifidobacterium lactis Howaru. 50mg FOS as RaftiloseTM


2. WHAT MIBIOTIX SP SHAPE CAPSULES ARE USED FOR:

Weight gain may be caused by disturbances to the gut lining. All health and wellbeing starts with the gut. When taken on a regular basis MiBiotix SP SHAPE CAPSULES will support the microflora balance in the gut and the gut lining. Remember to “Always start with your gut”.


3. BEFORE YOU TAKE/ USE/ ARE GIVEN/ ADMINISTERED MIBIOTIX SP SHAPE CAPSULES:

Do NOT take/use MiBiotix SP SHAPE CAPSULES: 

  • If you are known to be hypersensitive (allergic) to (active ingredient) or any of the inactive ingredients. 

Take special care with MiBiotix SP SHAPE CAPSULES:
MiBiotix SP SHAPE CAPSULES does not intend to prevent or cure any form of illness or disease and should not replace any medication. If you suffer from a chronic medical condition, consult your healthcare practitioner before using this product. Do not exceed the recommended dose.

Driving and using machinery:

No studies on the effect on the ability to drive or use machinery have been performed. It is unlikely that MiBiotix SP SHAPE CAPSULES would affect your ability to drive or use machinery. However, please exercise care until you are certain that your ability to perform such activities is not affected.

Important information about some of the ingredients of MiBiotix SP SHAPE CAPSULES:

All inactive ingredients added on the formulation of MiBiotix SP SHAPE CAPSULES are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix SP SHAPE CAPSULES:

Always tell your healthcare professional if you are taking other medicines. (This includes complementary or traditional medicine). The use of MiBiotix SP SHAPE CAPSULES with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.


4. HOW TO TAKE/ USE MIBIOTIX SP SHAPE CAPSULES:
The usual dose is:
Take one MiBiotix SP Capsule once daily after breakfast. Always take MiBiotix SP SHAPE CAPSULES exactly as per recommendation of the Package Insert or by your health care provider and if you are unsure. If the symptoms worsen or persist, please consult your healthcare practitioner.
If you forget to take /miss a dose of MiBiotix SP SHAPE CAPSULES:

Always take MiBiotix SP SHAPE CAPSULES as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule (see “HOW TO TAKE MiBiotix SP SHAPE CAPSULES”). Do not take a double dose to make up for forgotten individual doses.


5. POSSIBLE SIDE EFFECTS:

There has not been a case of any side effects reported when taking MiBiotix SP SHAPE CAPSULES.

MiBiotix SP SHAPE CAPSULES can have side effects.

Not all side effects reported for MiBiotix SP SHAPE CAPSULES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MiBiotix SP SHAPE CAPSULES, please consult your healthcare provider for advice. Please report/ inform your doctor or pharmacist if you notice any side effects not mentioned in this leaflet. 


6. STORAGE AND DISPOSING OF MIBIOTIX SP SHAPE CAPSULES:

Store all MiBiotix SP SHAPE CAPSULES out of reach of children.

Store in a cool, dry place below or at 25 0 C.

Keep the container in the original packaging and in an outer carton.

Protect from light.

Do not store in a bathroom.

Do not use after expiry date stated on the label/carton and on the bottle.

Do not use MiBiotix SP SHAPE CAPSULES if you notice any visible signs of deterioration. 

Return all unused MiBiotix SP SHAPE CAPSULES to your pharmacist/supplier.

Do not dispose of unused MiBiotix SP SHAPE CAPSULES in drains or sewage systems (e.g. toilets).


7. PRESENTATION OF MIBIOTIX SP SHAPE CAPSULES:

MiBiotix SP SHAPE CAPSULES is packed in 30’s, in a white plastic bottle with a white cap in an outer carton.


8. IDENTIFICATION OF MIBIOTIX SP SHAPE CAPSULES:

Containing a white powder packed in a DR vegetarian capsule.


9. REGISTRATION NUMBER:

Will be allocated by Council upon registration. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.


10. NAME AND ADDRESS OF REGISTRATION HOLDER:

Kenza Health (Pty) Ltd Suite 177, Private Bag X7,  Northriding 2162
For professional information go to www.mibiotix.co.za


11. SCIENTIFIC SUPPORT

Clinical studies show that Bifidobacterium. lactis helps control body fat mass, truck fat mass, waist circumference and energy intake. Bifidobacterium. lactis has also been shown to increase lean body mass.


12. REFERENCES

Stenman et al. 2016. EBioMedicine

http://www.clevelandheartlab.com/wp-content/uploads/2013/09/hsCRP-Practitioner-One-Pager-CHL-D009b.pdf

Pepys and Hirschfield 2003. J Clin Invest

WebMD https://www.webmd.com/arthritis/about-inflammation#2

Hibberd et al. 2018. Beneficial Microbes (under peer review)

SantaCruz et al. 2010. British Journal of Nutrition 

Everard et al., 2013. Proceedings of the National Academy of Sciences of the United States of America

Dao et al., 2016. Gut



MIBIOTIX SP SHAPE CAPSULES 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix SP SHAPE CAPSULES.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix SP SHAPE CAPSULES (kapsules).

Lees die hele blaadjie sorgvuldig deur, want dit bevat belangrike inligting vir u.

MiBiotix SP SHAPE CAPSULES is beskikbaar sonder die voorskrif van ‘n dokter. U moet egter steeds MiBiotix SP SHAPE CAPSULES versigtig gebruik om die beste resultate daarmee te verkry.

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix SP SHAPE CAPSULES met enige ander persoon deel nie.
    • Vra jou apteker as jy meer inligting of advies benodig.
    • U moet ’n dokter raadpleeg indien u simptome vererger of nie verbeter nie.                                          


1. WAT MIBIOTIX SP SHAPE CAPSULES BEVAT:

10 Miljard KVEs of Bifidobacterium lactis Howaru. 50mg FOS as RaftiloseTM


2. WAARVOOR  MIBIOTIX SP SHAPE CAPSULES GEBRUIK WORD:

Versteurings in die dermkanaalwand kan veroorsaak dat ’n mens gewig optel. Alle gesondheid en welwees begin by die dermkanaal. Gereelde gebruik van MiBiotix SP SHAPE CAPSULES sal die mikroflorabalans in jou dermkanaal en dermkanaalwand ondersteun. Onthou om “Altyd by jou dermkanaal te begin”.


3. VOORDAT U MIBIOTIX SP SHAPE CAPSULES NEEM:

Moenie MiBiotix SP SHAPE CAPSULES gebruik as:

  • jy bewus is daarvan dat jy hipersensitief (allergies) is vir (aktiewe bestanddeel) of enige van die bestanddele. 

Neem Spesiale sorg met MiBiotix SP SHAPE CAPSULES:
MiBiotix SP SHAPE CAPSULES beoog nie om enige ongesteldheid of siektetoestand te genees nie en moet nie enige medikasie vervang nie. Mense wat aan ’n chroniese mediese toestand ly moet hulle gesondheidspraktisyn raadpleeg voor hulle hierdie produk gebruik. Moenie die voorgeskrewe dosis oorskry nie.

Bestuur en die gebruik van masjinerie:

Geen navorsingstudies is uitgevoer oor die effek op die vermoë om te bestuur of masjinerie te hanteer nie. Dit is onwaarskynlik dat MiBiotix SP SHAPE CAPSULES die vermoë om te bestuur of masjinerie te gebruik sal beïnvloed. Wees egter versigtig tot u seker is u vermoë om hierdie aktiwiteite uit te voer word nie beïnvloed nie.

Belangrike inligting oor sommige van die bestanddele van MiBiotix SP SHAPE CAPSULES:

Al die onaktiewe bestanddele wat op die formulering van MiBiotix SP SHAPE CAPSULES gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix SP SHAPE CAPSULES:

Lig altyd u gesondheidpraktisyn in wanneer u medisyne neem. (Dit sluit in komplementêre of tradisionele medisyne). Die gebruik van MiBiotix SP SHAPE CAPSULES saam met hierdie medisyne mag ongewenste wisselwerkings veroorsaak. Raadpleeg asseblief u dokter, apteker of ander professionele gesondheidsorgwerker vir advies.


4. HOE OM MIBIOTIX SP SHAPE CAPSULES TE GEBRUIK 

Die gewone dosis is:

Neem een MiBiotix SP SHAPE CAPSULE, daagliks na ontbyt.

Neem MiBiotix SP SHAPE CAPSULES altyd volgens aanbevelings van die pakketinvoer of deur u gesondheidsorgverskaffer en indien u onseker is. As die simptome vererger of voortduur, raadpleeg ’n gesondheidsorgpraktisyn.

As jy vergeet om ‘n dosis MiBiotix SP SHAPE CAPSULES te neem:

Neem MiBiotix SP SHAPE CAPSULES altyd soos voorgeskryf. Indien u ’n dosis vergeet het, neem dit sou gou as wat u onthou. Indien u egter nie van die vergete dosis onthou voordat dit tyd is vir die volgende dosis is nie, slaan die vergete dosis oor en keer terug na u gewone doseringskedule (sien “HOE OM MiBiotix SP SHAPE CAPSULES TE GEBRUIK”). Moenie ’n dubbele dosis neem om te vergoed vir die oorgeslane individuele dosis nie.


5. MOONTLIKE NEWE EFFEKTE

Daar was nie gevalle van enige newe-effekte gerapporteer wanneer MiBiotix SP SHAPE CAPSULES geneem word nie.

MiBiotix SP SHAPE CAPSULES kan newe-effekte hê.

Nie alle newe-effekte wat vir MiBiotix SP SHAPE CAPSULES gemeld is, is in hierdie inligtingstuk vervat nie. Indien u algemene gesondheid agteruitgaan of u ongewenste wisselwerkings ervaar terwyl MiBiotix SP SHAPE CAPSULES gebruik, raadpleeg asseblief u gesondheidsorgvoorsiener vir advies. Lig asseblief u dokter of apteker in indien u enige newe-effekte opmerk wat nie in hierdie inligtingstuk genoem word nie.


6. BERGING EN WEGDOEN VAN MIBIOTIX SP SHAPE CAPSULES:

Bewaar alle MiBiotix SP SHAPE CAPSULES buite bereik van kinders.

Berg in ‘n koel, droë plek onder of by 25 ° C.

Hou die houer in die oorspronklike verpakking en in ‘n buitenste karton.

Beskerm teen lig.

Moenie in ‘n badkamer stoor nie.

Moet nie gebruik word na die vervaldatum wat op die etiket / karton en op die bottel aangedui word nie.

Moenie MiBiotix SP SHAPE CAPSULES gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte MiBiotix SP SHAPE CAPSULES na u apteker / verskaffer terug.

Moet nie ongebruikte MiBiotix SP SHAPE CAPSULES in riool- of rioolstelsels gooi  nie (byvoorbeeld toilette).


7. AANBIEDING VAN MiBiotix SP SHAPE CAPSULES:

MiBiotix SP SHAPE CAPSULES is verpak in 30’s, in ‘n wit plastiekbottel met ‘n wit dop en in ‘n buitenste karton.


8. IDENTIFIKASIE VAN MiBiotix SP SHAPE CAPSULES:

Wit poeier verpak in n DR vegetariese kapsule.


9. REGISTRASIENOMMER:

Sal deur die Raad toegeken word by registrasie. Hierdie ongeregistreerde medisyne is nie deur die SAHPRA geevalueer ten opsigte van kwaliteit, veiligheid of beoogde gebruik nie.


10. NAAM EN ADRES VAN DIE HOUER VAN DIE REGISTRASIE:

Kenza Health (Edms) Bpk Suite 177, Private BagX7, Northriding 2162

Vir proffessionele inligting gaan na www.mibiotix.co.za


11. DATUM VAN PUBLIKASIE:

August 2019; PI.059.1.8.19